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Effect of NUV001 Supplementation in Patients Suffering From Sickle Cell Disease (SCD)
Sponsor: LGD
Summary
This is a pilot study of daily dosing of NUV001 as a dietary supplement in 12 sickle cell disease patients with 3 months of follow-up plus 1 month after supplementation.The present study is designed to evaluate, first, the safety and tolerability parameters as well as to measure the plasma and urinary residues of daily oral doses of NUV001. Secondly, the study will evaluate the impact of NUV001 on biological parameters and quality of life of patients.
Official title: Effect of NUV001 Supplementation for 120 Days in Patients Suffering From Sickle Cell Disease (SCD) S Homozygous (SS) Genotype: A Pilot Study
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2023-04-01
Completion Date
2024-06-30
Last Updated
2024-05-28
Healthy Volunteers
No
Conditions
Interventions
NUV001
Daily supplementation with NUV001 at 1000 mg (4 tablets of 250 mg each) for 90 days with a prolonged follow-up of 1 month (30 days) after stopping the supplementation
Locations (1)
Aphm Hopital La Timone Adultes Sce Medecine Interne (Umap)
Marseille, France